[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640044":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":22,"locations":31,"responsibleParty":45,"collaborators":17,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":17,"enrollmentInfo":57,"targetDuration":17,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":17,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Centre Henri Becquerel","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography","EXPERIMENTAL","Patients will undergo an \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb PET\u002FCT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery",[13],"Other: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography",[15],{"type":6,"name":9,"description":11,"armGroupLabels":16,"otherNames":17},[9],null,[19],{"name":20,"affiliation":5,"role":21},"Florian Clatot, MD, PhD","PRINCIPAL_INVESTIGATOR",[23,27],{"name":20,"role":24,"phone":25,"phoneExt":17,"email":26},"CONTACT","+33232082981","florian.clatot@chb.uncancer.fr",{"name":28,"role":24,"phone":29,"phoneExt":17,"email":30},"Doriane Richard, PhD","+33232082985","doriane.richard@chb.unicancer.fr",[32],{"facility":5,"status":17,"city":33,"state":17,"zip":17,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Rouen","France","FR",{"type":37,"coordinates":38},"Point",[39,40],1.09932,49.44313,{"lat":40,"lon":39},[43],{"name":20,"role":24,"phone":25,"phoneExt":17,"email":44},"florian.clatot@chb.unicancer.fr",{"type":46,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100640044","phase-2-evaluation-of-68gaga-nota-anti-her2-sdab-petct-for-predicting-pathological-complete-response-after-neoadjuvant-chemotherapy-in-her2-positive-early-breast-cancer-100640044",false,"NCT07593976","Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer","Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer (GATHER): a Study Protocol for a Monocentric, Prospective, Interventional, Phase 2, Imaging Biomarker Trial.","GATHER","Inclusion Criteria:\n\n* Female aged 18 years or older\n* Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification\n* Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board\n* ECOG performance status of 0 or 1\n* Affiliated to or beneficiary of a social protection scheme\n* Written informed consent signed prior to any study-specific procedure\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n\n  * Patient not treated with curative intent\n  * History of ipsilateral breast cancer treated by surgery and\u002For radiotherapy\n  * Lobular histology\n  * Known contraindication or hypersensitivity to \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients\n  * Known contraindication or hypersensitivity to \\[18F\\]F-FDG or any of its radiopharmaceutical excipients\n  * Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals\n  * Patient under guardianship, curatorship, or judicial protection\n  * Patient deprived of liberty\n  * Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers","FEMALE","18 Years",{"count":58,"type":59},42,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","The GATHER trial aim to evaluate the diagnostic performance of \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb PET\u002FCT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.",[65],"Breast Cancer",[67,68,69,70],"early breast cancer","Positron emission tomography","Gallium radioisotopes","pathological complete response","NOT_YET_RECRUITING","2026-05-12",{"date":74,"type":75},"2026-05-18","ACTUAL",{"date":77,"type":59},"2026-09-01",{"date":79,"type":59},"2028-03-01",{"name":5,"class":6},1]